MTS Systems OrthoGold100 OW100-US User manual

1 MTS_OW100_IFU-orthogold100-US-K182682_A
Instructions for Use
OrthoGold100®
Model: OW100-US
(US-510K, K182682)
Revision A, 2019-01-09
Caution: Federal law restricts this device to sale by or on the order of a physician.

2 MTS_OW100_IFU-orthogold100-US-K182682_A
Table of Contents
Glossary...........................................................................................................................................5
Symbols Used in this Document .............................................................................................................................................................5
Symbols Used on the Product Labels.....................................................................................................................................................6
1. Introduction...............................................................................................................................9
2. Device Information....................................................................................................................9
2.1 Indications for Use ........................................................................................................................................................................9
2.2 Contraindications ..........................................................................................................................................................................9
2.3 Warnings.....................................................................................................................................................................................10
2.4 Cautions......................................................................................................................................................................................10
2.5 Device Description......................................................................................................................................................................11
3. Set-up Instructions..................................................................................................................20
3.1 Applicator....................................................................................................................................................................................23
3.2 Applicator Connection.................................................................................................................................................................25
3.3 Changing and disconnection of applicator...................................................................................................................................26
3.4 Water Cartridge...........................................................................................................................................................................29
3.5 Connect the Footswitch...............................................................................................................................................................31
3.6 Menu setup.................................................................................................................................................................................32
4Operating Instructions.............................................................................................................33
4.1 Setting the Output Parameters....................................................................................................................................................43
4.2 Acoustic wave treatment.............................................................................................................................................................51
5Emergency Procedures...........................................................................................................55
6Cleaning Instructions...............................................................................................................55
6.1 Maintenance ...............................................................................................................................................................................55
6.2 Storage.......................................................................................................................................................................................56
6.3 Disposal of the Device................................................................................................................................................................56
7Technical, Electrical, & EMC...................................................................................................57
7.1 Electrical and EMC .....................................................................................................................................................................57
7.2 Standards ...................................................................................................................................................................................63
8. Troubleshooting ......................................................................................................................64
9. Additional Information .............................................................................................................67
Ordering................................................................................................................................................................................................67
Product Liability & Warranty..................................................................................................................................................................67
Transport..............................................................................................................................................................................................67
Return for Service.................................................................................................................................................................................68

3 MTS_OW100_IFU-orthogold100-US-K182682_A
Tables
Table 1: List of delivered parts with the OW100®..................................................................................... 21
Table 2 Recommended safety distances between Mobile HF Telecommunication Devices and the
OW100®.................................................................................................................................................. 57
Table 3 Electromagnetic Interference...................................................................................................... 59
Table 4 Resistance to Electromagnetic Interference ............................................................................... 60
Table 5 Guidance and manufacturer´s declaration.................................................................................. 61
Table 6 Troubleshooting Issues .............................................................................................................. 64
Figures
Figure 1 Function Principle of acoustic wave creation with the OW100
®
............................................ 11
Figure 2 Components and connections of the OW100
®
at the front side ............................................ 12
Figure 3 Components and connections of the OW100
®
at the rear side ............................................. 13
Figure 4 Applicator ................................................................................................................................. 14
Figure 5 Water cartridge of the OW100
®
at the rear side ..................................................................... 15
Figure 6 Front side connections of the OW100
®
................................................................................... 16
Figure 7 Connections at the rear side .................................................................................................... 17
Figure 8 Applicator connection socket (left) and connect applicator (right) ......................................... 18
Figure 9 Display of the OW100
®............................................................................................................ 18
Figure 10 Touch panel (left) and touch wheel (right) of the OW100
®
................................................... 19
Figure 11 Footswitch .............................................................................................................................. 19
Figure 12 Installation of power supply..................................................................................................... 22
Figure 13 Applicator connection - inside view (left) and socket (right) ................................................. 24
Figure 14 Connected applicator ............................................................................................................. 24
Figure 15 Display of the connected applicator at the OW100
®
............................................................ 24
Figure 16 Applicator drain control............................................................................................................ 28
Figure 17 Pit for water cartridge (1) ....................................................................................................... 29
Figure 18 Unlocked water cartridge ....................................................................................................... 29
Figure 19 Inserted and locked water cartridge (2) ................................................................................ 29
Figure 20 Water cartridge of the OW100
®
shown from above (left) and from front side (right) .......... 30
Figure 21 Set-up Menu of the OW100
®
................................................................................................. 31
Figure 22 Connected Footswitch ........................................................................................................... 31
Figure 23 "SETUP' Key field .................................................................................................................. 32
Figure 24 Power switch activated .......................................................................................................... 37
Figure 25 Step 3 - when to press the confirmation button .................................................................... 37
Figure 26 Start screen of the OW100
®
with displayed software version .............................................. 37
Figure 27 Operation screen ................................................................................................................... 38
Figure 28 "FILL" key on the display ....................................................................................................... 39
Figure 29 Touch panel of the OW100
®
.................................................................................................. 44
Figure 30 Touch wheel of the OW100
®
................................................................................................. 45
Figure 31 Options for "ENERGY" on the display .................................................................................. 45
Figure 32 Beam pressure maximum and target Location ..................................................................... 46
Figure 33 Dependence of the pressure pulse parameters on the generator............................................ 47
Figure 34 Dependence of the acoustic pulse energy on the generator.................................................... 48
Figure 35 Dependence of the pressure pulse parameters on the generator ....................................... 48
Figure 36 Setting the frequency at the display ...................................................................................... 49
Figure 37 Pre-set of the number of shots for one treatment ................................................................. 50
Figure 38 Display of the connected applicator types at the display of the OW100
®
............................ 50
Figure 39 Display of the remaining acoustic waves on the applicator ................................................. 51

4 MTS_OW100_IFU-orthogold100-US-K182682_A
Figure 40 Example of an error message. The picture shows, that there are several error messages
piled up ................................................................................................................................................... 66
Figure 41 Example of a warning message ............................................................................................ 66
Figure 42 Example of Information Error ................................................................................................ 66
Figure 43 Transport box OW100
®
- Closed (left), opened with device (right) ...................................... 68
Figure 44 Applicator packaging opened. Send back the used applicator and the water cartridge. ....... 69

5 MTS_OW100_IFU-orthogold100-US-K182682_A
Glossary
Symbols Used in this Document
This symbol indicates articles in which additional information
and/or hints to the respective circumstances are given.
Warning: read user manual
Warning´: Ear protection
Connection assignment for the footswitch
Connection assignment for the memory card
Connection assignment for the USB interface
Connection assignment for the primary fuses

6 MTS_OW100_IFU-orthogold100-US-K182682_A
Symbols Used on the Product Labels
Symbol
Meaning
Ref. ID*
Refer to instruction
manual/booklet
M002
CAUTION
0434A
Manufacturer
3082
Date of manufacture
2497
Temperature
0632
Humidity
2620
Atmospheric pressure limitation
2621
Type B applied part
5840
Foot switch
5114
Applicator
4349
* ISO 7000: Graphical Symbols For Use On Equipment - Registered Symbols

7 MTS_OW100_IFU-orthogold100-US-K182682_A
The following labels are attached to the device or the
applicator:
Type plate of the basic unit, exemplified:
Type plate of the transport box, exemplified:
Type plate of the footswitch, exemplified:

8 MTS_OW100_IFU-orthogold100-US-K182682_A
Type plate of the applicator, exemplified:
Type plate of the cartridge, exemplified:
Type plate of the applicator packaging, exemplified:

9 MTS_OW100_IFU-orthogold100-US-K182682_A
1.Introduction
This manual instructs the user in the proper use and operation of the of the
OrthoGold100®device. Please read these instructions carefully before starting treatment.
The user must thoroughly understand the information presented in this manual and
inform the patient of all risks associated with the treatment. Additionally, regular
maintenance of the device must be completed according to these instructions.
This instruction for use indicates the model name OW100-US also as
OW100 for simplification.
2.Device Information
2.1 Indications for Use
The OrthoGold100®is intended for the activation of connective tissue.
2.2 Contraindications
Contraindication –A contraindication indicates a situation in which the device should not be used.
Do not use the OrthoGold100®in patients with pacemakers or implantable
defibrillators.
Do not use the OrthoGold100®in patients who are using devices which are
sensitive to electromagnetic radiation.
Do not use the OrthoGold100®in confirmed or suspected pregnancy.
Do not use the OrthoGold100®close to the reproductive system in females of
childbearing potential. The application of acoustic waves to this patient population
could possibly result in irreversible damage to the female reproductive system and
to the unborn fetus in an undiagnosed pregnancy.
Do not use the OrthoGold100®for the treatment of vertebrae, skull bones and
ribs.
Do not adjust the therapy beam on internal organs (especially lungs).
Do not use the OrthoGold100®for the treatment of infected pseudarthrosis in the
acute state.
Do not use the OrthoGold100®for the treatment of patients with tumors.
Do not use the OrthoGold100®for the treatment of patients with severe
coagulation disorders.
Do not use the OrthoGold100®for extracorporeal acoustic wave lithotripsy
Do not use the OrthoGold100®for the treatment of patients younger than 18
years or of patients with open epiphyseal plates.
Do not direct the acoustic waves on large nerves.
Do not direct the acoustic waves on large vessels.

10 MTS_OW100_IFU-orthogold100-US-K182682_A
Do not direct the acoustic waves on internal air-filled organs (especially lungs).
All other Contraindications mentioned in scientific literature
Do not use in areas where skin surface is broken or an open wound exist.
Never use this device on children, the unconscious, or anyone who cannot give verbal
consent or warnings about pain.
Do not direct the acoustic wave treatment on air- filled internal organs (especially
lungs). Do not use on the back or chest.
Do not direct the acoustic wave treatment on esophagus.
Do not direct the acoustic wave treatment on the ears.
Do not direct the acoustic wave treatment on the head.
Do not direct the acoustic wave treatment on the spinal column.
Do not use in the presence of unexplained pain.
Do not treat wounds, infected areas, skin tumors, open sores, or scars from
recent surgery.
2.3 Warnings
WARNING
A warning indicates a situation which, if not
avoided, could result in death or serious injury.
The OW100®may only be used by trained physicians (medical specialist) with
adequate medical and technical experience in acoustic wave treatments.
Use of this device may give rise to undesirable heart reactions. The patient must
be continuously observed during the treatment.
If a patient experiences cardiac arrhythmia during treatment or a kind of uneasy
feeling, acoustic wave delivery should be terminated.
If a patient reports significant or unexpected pain, immediately stop the treatment
and consult a physician.
Avoid possible bruising. Use caution when determining a patient’s sensitivity
level.
This device should not be used over swollen or inflamed areas or skin eruptions.
2.4 Cautions
CAUTION
A caution indicates a situation which, if not avoided, may result in minor
or moderate injury to the user or patient or damage to the OW100®
equipment or other property.
Potential effects associated with acoustic wave treatments include those listed below:
There is a potential for discomfort when using the OW100®on bony surfaces. Be aware
of the potential for bruising.
Use of this device may be painful or cause bruising or cavitation.
Always protect patients and medical personnel with appropriate noise protection
measures, e.g. provide ear protectors.

11 MTS_OW100_IFU-orthogold100-US-K182682_A
Transient moderate increase in pain
Redness and swelling
Hematoma and petechial hemorrhage
Headaches and fainting during extracorporeal acoustic wave treatments
Short-term hypaesthesia
Nausea during therapy
Tingling during therapy
2.5 Device Description
Overview
The OrthoGold100®, also referred to as the OW100®, is a transportable device for
therapeutic acoustic wave treatment. It is comfortable in handling and operating. The
OrthoGold100®is intended for the activation of connective tissue in the upper and
lower extremities.
The OW100®generates electrohydraulic acoustic waves by discharge of high voltage
(spark) at a submerged electrode (Figure 1). The spark promptly vaporizes the
medium between the electrode tips and creates a spherical, acoustic wave. At the
reflector, the acoustic wave is unfocused (OP 155).
Positioning of the reflector allows transmitting the acoustic wave onto the treatment
area at the patient. The coupling of the applicator to the treatment area (5) is to be
carried out with the silicone membrane (4) and ultrasound gel.
Figure 1
Function Principle of acoustic wave creation with the OW100
®

12 MTS_OW100_IFU-orthogold100-US-K182682_A
Front View
The OW100®contains the water circuit, the high voltage parts, the electrohydraulic
acoustic wave generator, the voltage supply and the microprocessor.
The following parts are accessible from the outside:
The applicator (1), in which the acoustic waves are generated and modulated.
The applicator will be connected by means of the applicator connector to the
device. The OW100®recognizes the connected applicator type automatically and
shows the name on the display.
By means of the footswitch (6) or the acoustic wave release button at the
applicator, acoustic waves can be released. The footswitch is connected to the
device at the front side.
The touch screen (2) serves to adjust the treatment- and device parameters.
Also the touch wheel (3) serves to adjust the treatment- and device parameters
The power switch (7) serves to switch on and off the voltage supply of the device.
Figure 2 Components and connections of the OW100
®
at the front side

13 MTS_OW100_IFU-orthogold100-US-K182682_A
Rear View
The power supply socket (8) serves to connect the delivered power cable.
The use of the memory card slots (9) is meant only for service purpose. The
memory card stores the technical errors appearing during operation and the Log-
files.
The USB connector (10) is also meant only for service purpose only.
The water cartridge (11) (should be exchanged according to the request of the
device).
8 Connecting socket for the
detachable power cable
9 Slot for the memory card (only for
service purpose)
10 USB connection (only for service
purpose)
11 Water cartridge
Figure 3
Components and connections of the OW100
®
at the rear side
Acoustic wave generator
The acoustic wave generator full fills the following tasks:
Creation and control of the high voltage for the discharge at the electrode.
Creation and control of the trigger signal. The OW100®commands the following
trigger modes:
Acoustic wave release per footswitch
Acoustic wave release per button at the applicator
The acoustic wave release frequency varies between 0.5 to 8 pulses (acoustic
waves) per second.

14 MTS_OW100_IFU-orthogold100-US-K182682_A
Applicator
The applicator is delivered as an accessory. The total number of acoustic waves
available in the applicator are 100,000 acoustic waves at an energy level of 1-10. At
an energy level of 11-16 the number of total acoustic waves 70 000. Once the
applicator is depleted, it should be exchanged with a new one. The device shows
the residual number of acoustic waves (Figure 34). The number of acoustic
waves per treatment session is dependent upon the indication. For the activation of
connective tissue, the recommended paradigm is 2000 acoustic waves delivered per
treatment session. However, the health care provider must use their best judgment for
the patient based upon anatomy and treatment area.
The applicator consists of the following parts (Figure 4):
1 Applicator housing
2 Water membrane
3 Acoustic wave release button
Figure 4 Applicator
The applicator delivers the acoustic waves to the treatment area of the patient. The
contact will be achieved via the water membrane (2) and ultrasound gel.
The applicator contains:
Electrode (not visible in the picture)
Reflector (not visible in the picture)
Water membrane (2)
The applicator is connected to the basic unit via a connection adapter. In the
insulated, flexible hose of the applicator there are the high voltage cable, the water
supply hoses and the electric signal cable located.

15 MTS_OW100_IFU-orthogold100-US-K182682_A
The applicator serves the following tasks:
Generation and emission of unfocused acoustic waves
The applicator is filled with water to enable the generation and the transport of the
acoustic waves. The special shape of the reflector (OP155) allows reflecting the
acoustic waves in an unfocused pressure field outside the applicator.
Coupling to the patient
The patient coupling is achieved via water membrane and ultrasound gel, applied to
the treatment area. The release of acoustic waves is initiated either via the connected
footswitch or via the acoustic wave release button (3) on the applicator.
Release button on the applicator to initiate/control release of acoustic waves.
Water circuit
On the rear side of the device the water cartridge drawer is located (Figure 5, #1).
The water circuit of the OW100®fulfills the following tasks:
Figure 5 Water cartridge of the OW100
®
at the rear side
Providing of the water which is necessary for the generation of acoustic waves.
Also filtering of the electrode mud in the water. The water cartridge must be
exchanged with every applicator exchange or by request of the device (the
device will display a blue message box indicating that the water cartridge must
be exchanged.) This message will appear if the water cartridge depletes prior
to the applicator exchange.
Filling and draining of the applicator.
Coupling pressure
The water pressure is preset to one single pressure level. Thus the water membrane
has a fixed out arcing which cannot be changed by the user. The following table shows
the out arcing of the water membrane and the penetration depth for the treatment.

16 MTS_OW100_IFU-orthogold100-US-K182682_A
Water
Pressure
Level
Applicator / membrane Image
Outarcing
of
membrane
[mm]
Penetration
depth (-6dB) at
energy level 16
[mm]
Not
adjustable
by user
13
25,4
Probe Cover
A general-purpose probe cover or sheath should be used for each patient or treatment area
to avoid possible contamination of the membrane or cross contamination between patients or
sites. The recommended probe cover is a disposable general purpose probe cover
manufactured by MicroTek EcoLab measuring 13cm x 61cm (5in x 24 in). Microbio-Medics:
Microtek Probe Drape FDA cleared in K882724 or equivalent, disposable, single use does not
contain latex.
Front Side Connections
Footswitch connection (Figure 6, #1):
The footswitch connection (1) is situated at the left. Please connect only the
provided footswitch (Steute, Type RF 2S- MED-AP).
The footswitch allows you to release acoustic waves.
Power switch (Figure 6, #2):
The power switch supplies the OW100®with voltage. When the device is in on- state,
a lamp in the switch is illuminated. It is also illuminated if the device is in stand-by-
mode (screen is dark).
Figure 6 Front side connections of the OW100
®
NOTE
After switching on the OW100®the device is in stand-by-mode.
To switch on press the button of the touch wheel for more than 2
seconds.

17 MTS_OW100_IFU-orthogold100-US-K182682_A
Rear side connections
At the rear side, you will find the following connections:
Power connection socket (1)
Memory card slot (2)
USB-interface (3)
Water cartridge (4)
Figure 7
Connections at the rear side
Power connection socket (Figure 7, #1):
At the power connection socket, the provided power cable to supply the OW100®with
voltage is connected. The socket contains 2 primary fuses. Use only the delivered
power cable.
Memory card slot (Figure 7, #2):
SD- and MMC-memory cards fit into the memory card slot. The use is currently
provided only for designated service purpose by an authorized service engineer.
USB-interface (Figure 7, #3):
The USB interface is provided only for service purpose by an authorized service
engineer. Do not connect to any other devices!
Water cartridge (Figure 7, #4):
The water cartridge (delivered complete filled with water) must be exchanged, with
every applicator exchange or on request of the device (message on screen). It is
entirely closed and not refillable.

18 MTS_OW100_IFU-orthogold100-US-K182682_A
Side connections
At the left side of the device, the connection for the applicator is placed.
Figure 8 Applicator connection socket (left) and connect applicator (right)
Applicator (1)
Applicator connection socket (2)
Applicator connection plug (3)
The plug and the flexible hose contain the power- and water supply for the applicator.
The connection of the applicator happens automatically, which makes the connection
simple and comfortable.
Operating- and display elements (Figure 9)
The operation of the OW100®is performed by means of the touch panel (1) or touch
wheel (2) with confirmation button (3). Both input devices can use at any time, also in
a mixed mode. The adjustable parameters are dependent to the particular screen
menu.
Figure 9 Display of the OW100
®

19 MTS_OW100_IFU-orthogold100-US-K182682_A
Figure 10 Touch panel (left) and touch wheel (right) of the OW100
®
Footswitch (Figure 11) By activating the footswitch acoustic waves are released. The footswitch
has to be connected to the connection socket at the front side of the OW100®.
NOTE
Footswitch
Use only the provided footswitch (Steute, Type RF 2S-MED-AP)
of the OW100®
Figure 11 Footswitch
NOTE
Store package
Store for return after use.

20 MTS_OW100_IFU-orthogold100-US-K182682_A
3.Set-up Instructions
Unpack OW100
Open the transport box and take out the device and accessories.
Place the device on a firm surface. Ensure that the support is stable enough to hold
the weight of the device.
WARNING
Weight of OW100®
The OW100®weights approx. 16.5 kilograms (27 pounds). A
second person may be needed to take it out of the transport box.
WARNING
Operation of the OW100®
The OW100®must only be operated in a horizontal position.
NOTE
Transport box
Store the transport box to have it available for further transports.
WARNING
Visual Inspection!
Before using the OW100®check the device visually for damages.
If damages are detected: Do not use the OW100®and call the
technical service.
WARNING
Explosion Hazard!
Do not use the device in an environment where explosive and/or
inflammable substances are used or stored. In case of emergency
disconnect the power plug.
OW100®and accessories
The following parts are provided with the OW100®. This list can differ from the
delivery note/ invoice. Valid contents are in the delivery note/ invoice.